Microtesla Magnetic Therapy (MMT) Treatment of Post-acute Sequelae of SARS CoV-2 (PASC): Controlled Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Proportion of Successfully Completed Treatments
研究概览
简要总结
The purpose of this study is to assess the feasibility of an at-home MMT treatment in patients with cognitive dysfunction related to PASC, and to collect data on safety and efficacy to inform the design of larger clinical studies. A prospective randomized controlled study of 30 participants with PASC and moderate to severe cognitive dysfunction. Total study duration will be 8 weeks, including 4 weeks of treatment and 4 weeks of untreated follow up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Device Feasibility
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •English Speaking
- •SARS CoV-2 infection as documented by laboratory nucleic acid amplification test or antibody test ≥ 6 months from screening or signed attestation of positive test result
- •Experiencing PASC symptoms ≥ 6 months
- •Objective cognitive impairment on neuropsychological measures (as defined by a z-score ≥1 standard deviation below the normative mean) in executive functioning
- •Individuals of childbearing age agreeing to use a highly effective form of birth control
排除标准
- •History of cognitive dysfunction present prior to SARS CoV-2 infection
- •Febrile (> 99 F) at the time of the enrollment visit
- •Enrollment in another interventional clinical trial in the last 90 days or during the study period
- •Recent SARS CoV-2 reinfection in the last 30 days or during the study period
- •Recent SARS CoV-2 vaccination in the last 30 days or plans to be vaccinated during the 8 week study period
- •Currently taking immunomodulatory medication on an ongoing basis (NSAIDs, corticosteroids, cytokine antagonists, IVIG)
- •History of bipolar disorder, psychotic disorder, substance use disorder
- •Change in anti-depressant or other psychoactive medication or dose in the last 90 days
- •Cranially implanted devices or metal
- •Any serious unstable medical or neurologic condition
- •History of severe head injury (as defined by loss of consciousness for ≥30 minutes) or stroke in the past 12 months
- •Pregnant or plan to become pregnant during the study as indicated by positive pregnancy test
- •Serious immune/autoimmune diagnoses prior to SARS-CoV-2 infection
- •ME/CFS diagnosis prior to first SARS-CoV-2 infection
- •Existing diagnosis of Post-treatment Lyme Disease Syndrome
- •Inability to achieve appropriate positioning of the study device on the head
研究组 & 干预措施
Active device
The active device will generate a low amplitude magnetic field. 20 participants will be randomized to this arm.
干预措施: Pascal device (Device)
Sham device
The sham device will not generate a low amplitude magnetic field. 10 participants will be randomized to this arm.
干预措施: Sham Device (Device)
结局指标
主要结局
Proportion of Successfully Completed Treatments
时间窗: End of treatment, 4 weeks
Feasibility of using the device at home will be measured based upon the proportion of successfully completed treatments.
次要结局
- Device comfort(End of treatment, 4 weeks)
- Device ease of use(End of treatment, 4 weeks)
- Clarity of instructions(End of treatment, 4 weeks)
研究者
David Putrino
Professor
Icahn School of Medicine at Mount Sinai